A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 8
- 主要终点
- Primary objective
研究概览
简要总结
The study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. Study population will include patients over the age of 18 years.
The study will recruit patients presenting with suspicion of acute infection/sepsis and healthy individuals.
Study main objective is to derive and verify a host response based score to predicte severe outcome.
详细描述
For determining disease severity each enrolled patient will be assigned as either "severe outcome patient" or "non severe outcome patient" according to predefined criteria. (or "healthy").
Participation in the study requires the collection of routine patient data and blood sample. Blood samples will be used for measurements of host biomarkers that predict disease severity. The blood samples will be collected upon enrollment.
In addition, a standardized patient questionnaire inquiring about severity outcomes met up to 28 days after presentation will be conducted by phone call 28 to 42 days post admission.
Enrolled patients will be managed according to the current standard of care per standard institutional procedures. Results of the measured biomarkers will not be revealed to the attending clinician and so will not influence patient management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Suspected acute infection/sepsis patients
- •Patients fulfilling the following criteria are not eligible for inclusion in this study:
- •HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records).
- •Pregnancy- self reported or medically confirmed. Healthy individuals
- •Patients fulfilling the following criteria are not eligible for inclusion in this study:
- •Episode of infection in the last 2 weeks
- •Major trauma and\or burns and\or surgery in the last 2 weeks
- •HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records)
- •Elective surgery patients
- •Pregnancy- self reported or medically confirmed
结局指标
主要结局
Primary objective
时间窗: 3,14 and 28 Days
To derive and verify the diagnostic performance of a host-response tool based on novel biomarkers for predicting disease severity in adult patients, aged 18 years or older, presenting with clinical suspicion of acute infection/sepsis.
次要结局
未报告次要终点